WO2025191401A1

WO2025191401A1 - Surgical stapling device with tissue gap control

Info

Publication number: WO2025191401A1
Application number: PCT/IB2025/052334
Authority: WO
Inventors: Vincent LAFRAGOLA; David M. Farascioni
Original assignee: Covidien LP
Current assignee: Covidien LP
Priority date: 2024-03-14
Filing date: 2025-03-04
Publication date: 2025-09-18
Anticipated expiration: 2026-09-14

Abstract

A surgical stapling device includes tool assembly having an anvil and a cartridge assembly that are coupled together to facilitate movement of the tool assembly between an open position and a clamped position to define a tissue gap between the staple cartridge and the anvil. The cartridge assembly includes a channel member that defines a cavity, a staple cartridge that is supported within the cavity of the channel member, and structure positioned between the staple cartridge and the channel member to selectively position the staple cartridge within the cavity of the channel member to control the size of the tissue gap.

Description

SURGICAL STAPLING DEVICE WITH TISSUE GAP CONTROL

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/565,268, filed March 14, 2024, which is incorporated herein by reference in its entirety.

FIELD

[0002] This disclosure is directed to surgical stapling devices and, more particularly, to surgical stapling devices including a tool assembly with tissue gap control.

BACKGROUND

[0003] Surgical stapling devices for ejecting staples to join tissue or tissue segments in a fast and efficient manner during a variety of surgical procedures are well known. Typically, a surgical stapling device includes a tool assembly having a first jaw that supports a cartridge assembly and a second jaw that supports an anvil. The cartridge assembly includes a staple cartridge that supports staples, and a channel member that defines a cavity and receives the staple cartridge. The first and second jaws are mounted together to allow movement of the tool assembly between an open position and a clamped position. In the clamped position, the staple cartridge of the cartridge assembly and the anvil are supported in juxtaposed alignment and include tissue contact surfaces that define a predetermined tissue gap. The predetermined tissue gap and the staples are dimensioned to receive and suture tissue having a thickness within a predetermined range to affect hemostasis of the tissue. If the tissue positioned between the jaws is outside the predetermined range, i.e., either too thick or too thin, the stapling device may not provide ideal hemostasis.

[0004] Accordingly, a continuing need exists in the suturing arts for a surgical stapling device that can provide effective hemostasis for a greater range of tissue thicknesses.

SUMMARY

[0005] This disclosure is directed to a surgical stapling device that includes a tool assembly having an anvil and a cartridge assembly that are coupled together to facilitate movement of the tool assembly between an open position and a clamped position to define a tissue gap between the staple cartridge and the anvil. The cartridge assembly includes a channel member that defines a cavity, a staple cartridge that is supported within the cavity of the channel member, and structure positioned between the staple cartridge and the channel member to selectively position the staple cartridge within the cavity of the channel member to control the size of the tissue gap.

[0006] Aspects of the disclosure are directed to a tool assembly including an anvil and a cartridge assembly. The anvil has a tissue engaging surface. The cartridge assembly is coupled to the anvil to facilitate movement of the tool assembly between an open position and a clamped position and includes a channel member, a staple cartridge, a first pair of shims, and a second pair of shims. The channel member has side walls and a bottom wall that together define a cavity. The staple cartridge is releasably received within the cavity of the channel member and includes a cartridge body, pushers, and staples. The cartridge body has a tissue engaging surface and defines a cartridge knife slot and staple receiving pockets positioned on each side of the cartridge knife slot. The tissue engaging surface of the cartridge body is spaced from the tissue engaging surface of the anvil when the tool assembly is in the clamped position to define a tissue gap. The first pair of shims has a first thickness and the second pair of shims has a second thickness that is different from the first thickness. The first pair of shims or the second pair of shims is positioned between the staple cartridge and the bottom wall of the channel member to support the staple cartridge within the cavity of the channel member.

[0007] Other aspects of the disclosure are directed to a surgical stapling device including a handle assembly, an elongate body, and a tool assembly. The elongate body has a proximal portion and a distal portion, and the proximal portion is coupled to the handle assembly. The tool assembly is coupled to the distal portion of the elongate body and includes an anvil having a tissue engaging surface and a cartridge assembly. The cartridge assembly is coupled to the anvil to facilitate movement of the tool assembly between an open position and a clamped position and includes a channel member, a staple cartridge, a first pair of shims, and a second pair of shims. The channel member has side walls and a bottom wall that together define a cavity. The staple cartridge is releasably received within the cavity of the channel member and includes a cartridge body, pushers, and staples. The cartridge body has a tissue engaging surface and defines a cartridge knife slot and staple receiving pockets positioned on each side of the cartridge knife slot. The tissue engaging surface of the cartridge body is spaced from the tissue engaging surface of the anvil when the tool assembly is in the clamped position to define a tissue gap. The first pair of shims has a first thickness and the second pair of shims has a second thickness that is different from the first thickness. The first pair of shims or the second pair of shims is positioned between the staple cartridge and the bottom wall of the channel member to support the staple cartridge within the cavity of the channel member.

[0008] Other aspects of the disclosure are directed to a cartridge assembly including a channel member, a staple cartridge, a first pair of shims, and a second pair of shims. The channel member includes side walls and a bottom wall that together define a cavity. The staple cartridge is releasably received within the cavity of the channel member and includes a cartridge body, pushers, and staples. The cartridge body has a tissue engaging surface and defines a cartridge knife slot and staple receiving pockets positioned on each side of the cartridge knife slot. The first pair of shims has a first thickness and the second pair of shims has a second thickness that is different from the first thickness. The first pair of shims or the second pair of shims is positioned between the staple cartridge and the bottom wall of the channel member to support the staple cartridge within the cavity of the channel member.

[0009] In aspects of the disclosure, the bottom wall of the channel member defines a channel knife slot that is longitudinally aligned with the cartridge knife slot when the staple cartridge is received within the cavity of the channel member.

[0010] In some aspects of the disclosure, a first shim of the first pair of shims or of the second pair of shims is positioned on a first side of the channel knife slot and a second shim of the first pair of shims or of the second pair of shims is positioned on a second side of the channel knife slot such that the channel knife slot is unobstructed by the first pair of shims or the second pair of shims.

[0011] In certain aspects of the disclosure, one side of each shim of the first pair of shims and the second pair of shims includes an adhesive.

[0012] In aspects of the disclosure, the adhesive on each of the first pair of shims and the second pair of shims is covered by a removable release strip.

[0013] In some aspects of the disclosure, the staple cartridge includes an actuation sled, and the actuation sled is movable through the cartridge body from a sled retracted position to a sled advanced position into engagement with the pushers to eject the staples from the cartridge body.

[0014] In certain aspects of the disclosure, the staple cartridge includes a staple guard that is secured to the cartridge body to retain the staples and the pushers within the cartridge body. [0015] In aspects of the disclosure, the first pair of shims or the second pair of shims is positioned between the staple guard and the bottom wall of the channel member.

[0016] Other aspects of the disclosure will be appreciated from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Various aspects of the disclosed stapling device are described herein below with reference to the drawings, wherein:

[0018] FIG. 1 is a side perspective view of a surgical stapling device including aspects of the disclosure with a tool assembly of the surgical stapling device in an open position;

[0019] FIG. 2 is a side perspective view of the distal portion of the stapling device shown in FIG. 1 with a staple cartridge and shims of a cartridge assembly of the tool assembly separated from the tool assembly;

[0020] FIG. 2A is a side perspective exploded view of the staple cartridge of the tool assembly shown in FIG. 2;

[0021] FIG. 3 is a view from one end of a plurality of shims of different thicknesses;

[0022] FIG. 4 is a side perspective view of the tool assembly of the stapling device shown in

FIG. 1 with the tool assembly in a clamped position;

[0023] FIG. 5 is a cross-sectional view taken along section line 5-5 of FIG. 4 illustrating the cartridge assembly with a shim having a first thickness;

[0024] FIG. 6 is a cross-sectional view taken along section line 5-5 of FIG. 4 illustrating the cartridge assembly with a shim having a second greater thickness;

[0025] FIG. 7 is a side perspective view of an alternate version of the tool assembly of the stapling device shown in FIG. 1 ;

[0026] FIG. 8 is a side perspective view of the distal portion of the tool assembly shown in FIG. 7 with a staple cartridge and shims of a cartridge assembly of the tool assembly separated from the tool assembly;

[0027] FIG. 9 is a perspective view from the distal end of a channel member and expandable balloon of the cartridge assembly of the tool assembly shown in FIG. 8;

[0028] FIG. 10 is a perspective view from the distal end of the channel member and the expandable balloon of the cartridge assembly of the tool assembly shown in FIG. 8 with the expandable balloon separated from the channel member; [0029] FIG. 11 is a side perspective view of the tool assembly of the stapling device shown in FIG. 8 with the tool assembly in a clamped position;

[0030] FIG. 12 is a cross-sectional view taken along section line 12-12 of FIG. 11 with the expandable balloon in a deflated state; and

[0031] FIG. 13 is a cross-sectional view taken along section line 12-12 of FIG. 11 with the expandable balloon in an inflated state.

DETAILED DESCRIPTION

[0032] The disclosed surgical stapling device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. However, it is to be understood that the disclosed aspects are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the disclosure in virtually any appropriately detailed structure.

[0033] In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. In addition, directional terms such as front, rear, upper, lower, top, bottom, and similar terms are used to assist in understanding the description and are not intended to limit the disclosure.

[0034] The disclosed surgical stapling device includes a tool assembly having an anvil and a cartridge assembly that are coupled together to facilitate movement of the tool assembly between an open position and a clamped position to define a tissue gap between the staple cartridge and the anvil. The cartridge assembly includes a channel member that defines a cavity, a staple cartridge that is supported within the cavity of the channel member, and structure positioned between the staple cartridge and the channel member to selectively position the staple cartridge within the cavity of the channel member to control the size of the tissue gap.

[0035] FIG. 1 illustrates a surgical stapling device shown generally as stapling device 10 that includes a handle assembly 12, an elongate body or adapter assembly 14, and a tool assembly 16. In aspects of the disclosure, the handle assembly 12 is powered and includes a stationary handgrip 18 and actuation buttons 20. The actuation buttons 20 are operable to actuate various functions of the tool assembly 16 via the adapter assembly 14 including approximation, stapling, and cutting. In certain aspects of the disclosure, the handle assembly 12 supports at least one motor (not shown) and batteries (not shown) that provide power to the handle assembly 12 to operate the stapling device 10. Although the stapling device 10 is illustrated as a powered stapling device, it is envisioned that the tool assembly 16 described herein is suitable for use with manually powered surgical stapling devices as well as robotically controlled stapling devices. [0036] The adapter assembly 14 includes a proximal portion 14a and a distal portion 14b. The proximal portion 14a is coupled to the handle assembly 12 and the distal portion 14b supports the tool assembly 16. The tool assembly 16 is coupled to the distal portion 14b of the adapter assembly 14 and includes a cartridge assembly 30 and an anvil 32. The anvil 32 includes a tissue engaging surface 32a (FIG. 5) that defines staple forming pockets (not shown) for forming staples 44 (FIG. 2A). The cartridge assembly 30 and the anvil 32 are coupled together to facilitate movement of the tool assembly 16 between an open position (FIG. 1) and a clamped position (FIG. 4). In the clamped position, the anvil 32 and the cartridge assembly 30 are in juxtaposed alignment with each other to define a tissue gap “Gl” (FIG. 5) between the tissue engaging surface 32a of the anvil 32 and the cartridge assembly 30. In aspects of the disclosure, the anvil 32 is stationary in relation to the adapter assembly 14 as the tool assembly 16 moves between the open position and the clamped position, and the cartridge assembly 30 pivots in relation to the anvil 32 between the open position and the clamped position. Alternately, it is envisioned that the anvil 32 could be coupled to the adapter assembly 14 to pivot in relation to the cartridge assembly 30.

[0037] FIGS. 2-4 illustrate the cartridge assembly 30, which includes a channel member 34, a staple cartridge 35, and a pair of shims 70. The channel member 34 includes side walls 36 and a bottom wall 38 that together define a cavity 34a having an open end spaced from the bottom wall 38 that receives the staple cartridge 35. The bottom wall 38 of the channel member 34 defines a knife slot 38a that extends along a substantial portion of the length of the channel member 34 and includes an open proximal end. The distal portions of the side walls 36 define recesses 36a. In aspects of the disclosure, the staple cartridge 35 is removably received within the cavity 34a of the channel member 34 to allow for replacement of the staple cartridge 35 after each firing of the stapling device 10 to facilitate reuse of the stapling device 10 (FIG. 1). [0038] FIG. 2A illustrates the staple cartridge 35 which includes a cartridge body 42, staples 44, pushers 46, an actuation sled 48, and a staple guard 50. The cartridge body 42 of the staple cartridge 35 is received within the cavity 34a defined by the channel member 34 and includes a tissue engaging surface 52 that is juxtaposed alignment with the tissue engaging surface 32a (FIG. 5) of the anvil 32 when the tool assembly 16 is in the clamped position to define the tissue gap “Gl” (FIG. 5). The cartridge body 42 defines a knife slot 54 and a plurality of staple receiving pockets 56 that are arranged in rows on each side of the knife slot 54. The knife slot 54 in the cartridge body 42 is aligned with the knife slot 38a in the channel member 34 when the staple cartridge 35 is positioned within the cavity 34a of the channel member 34. In certain aspects of the disclosure, the tissue engaging surface 52 of the cartridge body 42 of the staple cartridge 35 has a stepped configuration (FIG. 5) with a raised surface adjacent the knife slot 54 and lower surfaces positioned outwardly of the knife slot 54 towards the side walls 36 of the channel member 34. Each of the staple receiving pockets 56 receives one of the staples 44 (FIG. 3) and at least a portion of one of the pushers 46. In some aspects of the disclosure, the staples 44 in the inner rows of staple receiving pockets 56 are shorter in length than the staples 44 in the outer rows of staple receiving pockets 56. The actuation sled 48 is movable within the cartridge body 42 from a sled retracted position towards a sled advanced position into sequential engagement with the pushers 46 to urge the pushers 46 upwardly towards the anvil 32 and eject the staples 44 from the staple receiving pockets 56 of the cartridge body 42.

[0039] The cartridge body 42 includes side walls 60 (FIG. 5) that are positioned on opposite sides of the cartridge body 42. Each of the side walls 60 of the cartridge body 42 includes or supports overhangs 62 that extend outwardly from the tissue engaging surface 52 of the cartridge body 42. The overhangs 62 are formed integrally with, or fixedly secured to, the side walls 60 of the cartridge body 42 and include support surfaces 64 (FIG. 5) that are positioned on a lower portion of the overhangs 62. The support surfaces 64 of the overhangs 62 are positioned to engage the upper flat surfaces 37 of the side walls 36 of the channel member 34 (FIG. 5) as described below to support the staple cartridge 35 within the cavity 34a of the channel member 34.

[0040] The cartridge body 42 includes projections 69 (FIG. 2) that are received within the recesses 36a formed in the side walls 36 of the channel member 34. The projections 69 longitudinally align the staple cartridge 35 within the cavity 34a of the channel member 34 and guide the staple cartridge 35 as the staple cartridge 35 moves vertically within the cavity 34a of the channel member 34 between a raised position and a lowered position as described below. In aspects of the disclosure, the projections 69 have slip-resistant outer surfaces, e.g., ridged outer surfaces, that can be gripped by a clinician to facilitate insertion and removal of the staple cartridge 35 into and from the channel member 34.

[0041] The staple guard 50 is secured to a bottom side of the cartridge body 42 opposite to the tissue engaging surface 52 to retain the staples 44, the pushers 46, and the actuation sled 48 within the cartridge body 42. In aspects of the disclosure, the staple guard 50 includes flexible tabs 50a that define openings that receive protrusions 71 (FIG. 3) formed on an outer surface of the cartridge body 42 to secure the staple guard 50 to the cartridge body 42. In some aspects of the disclosure, the staple guard 50 also includes hooked fingers 50b that engage a proximal portion of the cartridge body 42 to secure a proximal portion of the staple guard 50 to the cartridge body 42 and hooked fingers 50c that engage a distal portion of the cartridge body 42 to secure a distal portion of the staple guard 50 to the cartridge body 42. The staple guard 50 also includes a bottom wall 51 that defines a knife slot 51a that is aligned with the knife slot 54 in the cartridge body 42.

[0042] The pair of shims 70 (FIG. 2) are formed of a rigid, non-compressible material and are supported on the bottom wall 38 of the channel member 34 between the bottom wall 51 (FIG. 2A) of the staple guard 50 and the bottom wall 38 of the channel member 34. In aspects of the disclosure, one shim 70 is positioned on each side of the knife slot 38a in the channel member 34 such that the knife slot 38a of the channel member 34 and the knife slot 54 of the cartridge body 42 are unobstructed by the pair of shims 70. When the staple cartridge 35 is inserted into the cavity 34a of the channel member 34, the staple cartridge 35 rests on top of the pair of shims 70 such that the staple cartridge 35 is spaced from the bottom wall 38 of the channel member a distance equal to the thickness of the pair of shims 70. In aspects of the disclosure, the shims 70 can include an adhesive 73 (FIG. 3) that is applied to one side of the pair of shims 70 to fixedly secure the shims 70 to the bottom wall 38 of the channel member 34. In some aspects of the disclosure, the adhesive 73 can be covered by release strips 73 a that can be removed immediately prior to positioning the pair of shims 70 onto the bottom wall 38 of the channel member 34.

[0043] In aspects of the disclosure, a plurality of pairs of shims 70, 70a, 70b, 70c, 70d (FIG. 3) are provided with each staple cartridge 35. Each pair of shims 70, 70a, 70b, 70c, 70d has a thickness that differs from the other pairs of shims 70, 70a, 70b, ,70c, 70d. In aspects of the disclosure, the pairs of shims 70, 70a, 70b, 70c, 70d have thicknesses that range from about 0.004 inch to about 0.010 inch but other thicknesses suitable for different applications are envisioned. In aspects of the disclosure, the surgical stapling device 10 can be provided in the form of a kit that includes the stapling device 10 (with the staple cartridge removed), one or more staple cartridges 35, and two or more of the pairs of shims 70, 70a, 70b, 70c, and 70d.

[0044] Prior to insertion of the staple cartridge 35 into the channel member 34 of the cartridge assembly 30, after a clinician has gauged the thickness of the tissue to be treated, the clinician can select one of the pair of shims 70, 70a, 70b, 70c, or 70d that affects the most desirable tissue gap for the tissue to be treated. The selected pair of shims 70, 70a, 70b, 70c, or 70d can be positioned onto the bottom wall 38 of the channel member 34 and the staple cartridge 35 can be positioned on the pair of shims 70, 70a, 70b, 70c, or 70d within the cavity 34a of the channel member 34. Each pair of shims 70, 70a, 70b, 70c, 70d positions the staple cartridge 35 at a different height within the cavity 34a of the channel member 34 to affect a different size tissue gap between the tissue engaging surface 32a of the anvil 32 and the tissue engaging surface 52 of the staple cartridge 35 when the tool assembly 16 is moved to the clamped position.

[0045] FIGS. 4 and 5 illustrate the tool assembly 16 in a clamped position. In aspects of the disclosure, the stapling device 10 includes a drive assembly 80 that includes a working member 82 having an I-beam configuration. The working member 82 includes an upper beam 84, a lower beam 86, and a vertical strut 88 that fixedly connects the upper beam 84 to the lower beam 86. The vertical strut 88 can support or be formed with a knife (not shown) having a distally facing cutting edge. The drive assembly 80 is movable from a drive retracted position through a drive clamped position to a drive advanced position to move the tool assembly 16 from the open position to the clamped position and to eject the staples 44 from the cartridge body 42 into the anvil 32. In the clamped position, the drive assembly 80 is in the drive clamped position such that the upper beam 84 is engaged with the anvil 32 and the lower beam 86 is engaged the channel member 34 of the cartridge assembly 30 to define the tissue gap “Gl”.

[0046] When thicker tissue “Tl” is to be treated with the stapling device 10, as illustrated in FIG. 5, a thin pair of shims, e.g., shims 70 (FIG. 3), can be positioned on the bottom wall 38 of the channel member 34 by a clinician prior to insertion of the staple cartridge 35 into the cavity 34a of the channel member 34. When the staple cartridge 35 is inserted into the cavity 34a of the channel member 34 onto the shims 70, the staple cartridge 35 moves into the cavity 34a of the channel member 34 to a position in which the support surfaces 64 of the overhangs 62 are positioned on the upper ends 36a of the side walls 36 of the channel member 34, the tissue engaging surface 32a of the anvil 32 is spaced from the tissue engaging surface 52 of the cartridge body 42 a maximum distance to define a large tissue gap “Gl” to receive the thicker tissue “Tl”.

[0047] When thinner tissue “T2” is to be treated with the stapling device 10, as illustrated in FIG. 5, a thicker pair of shims, e.g., shims 70d (FIG. 3), can be positioned on the bottom wall 38 of the channel member 34 by a clinician prior to insertion of the staple cartridge 35 into the cavity 34a of the channel member 34. When the staple cartridge 35 is inserted into the cavity 34a of the channel member 34 onto the shims 70d, the staple cartridge 35 moves into the cavity 34a of the channel member 34 to a position in which the support surfaces 64 of the overhangs 62 are spaced from the upper ends 36a of the side walls 36 of the channel member 34, and the tissue engaging surface 32a of the anvil 32 is spaced from the tissue engaging surface 52 of the cartridge body 42 a minimum distance to define a smaller tissue gap “G2” to receive the thinner tissue “T2”.

[0048] FIGS. 7-13 illustrate an alternate version of the tool assembly of the stapling device 10 of FIG. 1 shown generally as tool assembly 116. FIGS. 7 and 8 illustrate the tool assembly 116 which is like the tool assembly 16 (FIG. 2) and includes a cartridge assembly 130 and an anvil 132. The anvil 132 is identical to the anvil 32 and will not be described in further detail herein. The cartridge assembly 130 includes channel member 134, a staple cartridge 135, and an expandable balloon assembly 170. The channel member 134 includes side walls 136 and a bottom wall 138 that together define a cavity 134a that receives the staple cartridge 135. The channel member 134 and the staple cartridge 135 are identical to the channel member 34 and the staple cartridge 35 and will not be described in further detail herein.

[0049] FIGS. 9 and 10 illustrate the expandable balloon assembly 170 which includes a pair of balloons 172a and 172b, a fluid supply tube 174, and an actuator 176. The actuator 176 is coupled to the balloons 172a, 172b by the fluid supply tube 174 and is operable to deliver fluid through the fluid supply tube 174 to the balloons 172a, 172b to move the balloons 172a, 172b from a contracted state to an expanded state. In aspects of the disclosure, the actuator 176 can include a manually compressible bladder 180. Alternatively, the actuator 176 could include an electric compressor or the like. In aspects of the disclosure, a valve 182, e.g., a check valve, can be provided in the fluid supply line 174 between the actuator 176 and the balloons 172a, 172b to prevent fluid delivered to the balloons 172a, 172b from flowing back towards the actuator 176.

[0050] The balloons 172a and 172b are supported on the bottom wall 138 of the channel member 134 on opposite sides of the knife 138a between the staple guard 150 of the staple cartridge 135 and the bottom wall 138 of the channel member 134. In aspects of the disclosure, the fluid supply tube 174 is connected to the balloon 172b and the balloon 172b is connected to the balloon 172a by a transfer tube 178. Alternatively, the fluid supply tube 174 can be directly connected to each of the balloons 172a, 172b.

[0051] FIGS. 11 and 12 illustrate the tool assembly 116 in a clamped position with the balloons 172a and 172b in the contracted state. When thicker tissue “Tl” is to be treated with the tool assembly 116, the balloons 172a and 172b remain in their contracted states. When the staple cartridge 135 is positioned within the cavity 134a of the channel member 134 on the balloons 172a and 172b in their contracted states, the staple cartridge 135 moves into the cavity 134a of the channel member 134 to a position in which the support surfaces 164 of the overhangs 162 of the cartridge body 142 are positioned on the upper ends 136a of the side walls 136 of the channel member 134. In this position, the tissue engaging surface 132a of the anvil 132 is spaced from the tissue engaging surface 152 of the cartridge body 142 a maximum distance to define a large tissue gap “Gl” to receive the thicker tissue “Tl”.

[0052] FIG. 13 illustrates the tool assembly 116 in a clamped position with the balloons 172a and 172b in the contracted state. When thinner tissue “Tl” is to be treated with the tool assembly 116, the balloons 172a and 172b are moved to their expanded states. When the staple cartridge 135 is positioned within the cavity 134a of the channel member 134 on the balloons 172a and 172b and the balloons 172a and 172b are moved to their expanded states, the staple cartridge 135 moves upwardly towards the anvil 132 in the direction indicated by arrows “G” within the cavity 134a of the channel member 134 to a position in which the support surfaces 164 of the overhangs 162 of the cartridge body 142 are positioned above the upper ends 136a of the side walls 136 of the channel member 134. In this position, the tissue engaging surface 132a of the anvil 132 is spaced from the tissue engaging surface 152 of the cartridge body 142 a minimum distance to define a smaller tissue gap “G2” to receive the thinner tissue “T2”. It is noted that the balloons 172a and 172b can be expanded to any degree desired to define a tissue gap having a size anywhere between and including the tissue gap “Gl” and the tissue gap “G2”

[0053] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects of the disclosure. It is envisioned that the elements and features illustrated or described in connection with one exemplary aspect of the disclosure may be combined with the elements and features of another without departing from the scope of the disclosure. Also, one skilled in the art will appreciate further features and advantages of the disclosure based on the abovedescribed aspects of the disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A tool assembly comprising: an anvil having a tissue engaging surface; and a cartridge assembly coupled to the anvil to facilitate movement of the tool assembly between an open position and a clamped position, the cartridge assembly including a channel member, a staple cartridge, a first pair of shims, and a second pair of shims, the channel member having side walls and a bottom wall that together define a cavity, the staple cartridge releasably received within the cavity of the channel member and including a cartridge body, pushers, and staples, the cartridge body having a tissue engaging surface and defining a cartridge knife slot and staple receiving pockets positioned on each side of the cartridge knife slot, the tissue engaging surface of the cartridge body spaced from the tissue engaging surface of the anvil when the tool assembly is in the clamped position to define a tissue gap, the first pair of shims having a first thickness and the second pair of shims having a second thickness that is different from the first thickness, wherein the first pair of shims or the second pair of shims is positioned between the staple cartridge and the bottom wall of the channel member to support the staple cartridge within the cavity of the channel member.

2. The tool assembly of claim 1, wherein the bottom wall of the channel member defines a channel knife slot that is longitudinally aligned with the cartridge knife slot when the staple cartridge is received within the cavity of the channel member.

3. The tool assembly of claim 2, wherein a first shim of the first pair of shims or of the second pair of shims is positioned on a first side of the channel knife slot and a second shim of the first pair of shims or of the second pair of shims is positioned on a second side of the channel knife slot such that the channel knife slot is unobstructed by the first pair of shims or the second pair of shims.

4. The tool assembly of claim 1, wherein one side of each shim of the first pair of shims and the second pair of shims includes an adhesive.

5. The tool assembly of claim 4, wherein the adhesive on each of the first pair of shims and the second pair of shims is covered by a removable release strip.

6. The tool assembly of claim 1, wherein the staple cartridge includes an actuation sled, the actuation sled movable through the cartridge body from a sled retracted position to a sled advanced position into engagement with the pushers to eject the staples from the cartridge body.

7. The tool assembly of claim 6, wherein the staple cartridge includes a staple guard that is secured to the cartridge body to retain the staples and the pushers within the cartridge body.

8. The tool assembly of claim 7, wherein the first pair of shims or the second pair of shims is positioned between the staple guard and the bottom wall of the channel member.

9. A surgical stapling device comprising: a handle assembly; an elongate body having a proximal portion and a distal portion, the proximal portion coupled to the handle assembly; and a tool assembly coupled to the distal portion of the elongate body, the tool assembly including: an anvil having a tissue engaging surface; and a cartridge assembly coupled to the anvil to facilitate movement of the tool assembly between an open position and a clamped position, the cartridge assembly including a channel member, a staple cartridge, a first pair of shims, and a second pair of shims, the channel member having side walls and a bottom wall that together define a cavity, the staple cartridge releasably received within the cavity of the channel member and including a cartridge body, pushers, and staples, the cartridge body having a tissue engaging surface and defining a cartridge knife slot and staple receiving pockets positioned on each side of the cartridge knife slot, the tissue engaging surface of the cartridge body spaced from the tissue engaging surface of the anvil when the tool assembly is in the clamped position to define a tissue gap, the first pair of shims having a first thickness and the second pair of shims having a second thickness that is different from the first thickness, wherein the first pair of shims or the second pair of shims is positioned between the staple cartridge and the bottom wall of the channel member to support the staple cartridge within the cavity of the channel member.

10. The surgical stapling device of claim 9, wherein the bottom wall of the channel member of the cartridge assembly defines a channel knife slot that is longitudinally aligned with the cartridge knife slot when the staple cartridge is received within the cavity of the channel member.

11. The surgical stapling device of claim 10, wherein a first shim of the first pair of shims or of the second pair of shims is positioned on a first side of the channel knife slot and a second shim of the first pair of shims or of the second pair of shims is positioned on a second side of the channel knife slot such that the channel knife slot is unobstructed by the first pair of shims or the second pair of shims.

12. The surgical stapling device of claim 9, wherein one side of each shim of the first pair of shims and the second pair of shims includes an adhesive.

13. The surgical stapling device of claim 12, wherein the adhesive on each of the first pair of shims and the second pair of shims is covered by a removable release strip.

14. The surgical stapling device of claim 9, wherein the staple cartridge of the cartridge assembly includes an actuation sled, the actuation sled movable through the cartridge body from a sled retracted position to a sled advanced position into engagement with the pushers to eject the staples from the cartridge body.

15. The surgical stapling device of claim 14, wherein the staple cartridge of the cartridge assembly includes a staple guard that is secured to the cartridge body to retain the staples and the pushers within the cartridge body.

16. The surgical stapling device of claim 14, wherein the first pair of shims or the second pair of shims is positioned between the staple guard and the bottom wall of the channel member.

17. A cartridge assembly comprising: a channel member including side walls and a bottom wall that together define a cavity; a staple cartridge releasably received within the cavity of the channel member and including a cartridge body, pushers, and staples, the cartridge body having a tissue engaging surface and defining a cartridge knife slot and staple receiving pockets positioned on each side of the cartridge knife slot; a first pair of shims having a first thickness; and a second pair of shims having a second thickness that is different from the first thickness, wherein the first pair of shims or the second pair of shims is positioned between the staple cartridge and the bottom wall of the channel member to support the staple cartridge within the cavity of the channel member.

18. The cartridge assembly of claim 17, wherein the bottom wall of the channel member of the cartridge assembly defines a channel knife slot that is longitudinally aligned with the cartridge knife slot when the staple cartridge is received within the cavity of the channel member, a first shim of the first pair of shims or of the second pair of shims positioned on a first side of the channel knife slot and a second shim of the first pair of shims or of the second pair of shims positioned on a second side of the channel knife slot such that the channel knife slot is unobstructed by the first pair of shims or the second pair of shims.

19. The cartridge assembly of claim 17, wherein one side of each shim of the first pair of shims and the second pair of shims includes an adhesive.

20. The cartridge assembly of claim 19, wherein the adhesive on each of the first pair of shims and the second pair of shims is covered by a removable release strip.